Method and apparatus for ventilation/oxygenation during guided insertion of an endotracheal tube

ABSTRACT

An endotracheal tube can be inserted into a patient&#39;s trachea during resuscitation by using a face mask and a curved guide. The guide is inserted through a flexible port in the face mask and has a curved distal portion that extends into the patient&#39;s mouth and hypopharynx. The patient is initially resuscitated by supplying a flow of air/oxygen through the mask. An endotracheal tube is inserted over the distal end of a fiber optic probe. Resuscitation, oxygenation, or artificial ventilation continue without interruption while the fiber optic probe and endotracheal tube are inserted through a flexible port at the proximal end of the curve guide and then advanced along the guide into the patient&#39;s airway. The direction of the distal tip of the fiber optic probe can be controlled by the physician. This allows the physician to carefully guide the fiber optic probe and endotracheal tube to a position past the larynx while resuscitation continues. The fiber optic probe is then removed from within the endotracheal tube and the mask is removed while leaving the endotracheal tube in place within the trachea. The cuff on the endotracheal tube is inflated and a ventilator is connected to the proximal end of the endotracheal tube to ventilate the patient. Alternatively, the patient can be manually ventilated by connecting a resuscitation bag to the proximal end of the endotracheal tube.

RELATED APPLICATION

This application is a continuation of the Applicant's U.S. patentapplication Ser. No. 08/607,332 filed on Feb. 26, 1996, now U.S. Pat.No. 5,694,929 entitled "Method and Apparatus For Ventilation/OxygenationDuring Guided Insertion Of An Endotracheal Tube".

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to the field of respiratorydevices and methods. More specifically, the present invention disclosesa method and apparatus for guiding insertion of an endotracheal tubewhile the patient continues to receive cardiopulmonary resuscitation.

2. Statement of the Problem

In emergency situations involving cardiopulmonary patients or otherpatients with compromised or arrested breathing, an oral airway is firstinserted into the patient's mouth. A face mask is then placed over thepatient's mouth and nose. The face mask is connected to an inflatablebag to maintain at least minimal oxygen flow to the lungs in the shortterm. This process is sometimes referred to as "bagging" the patient. Itis suitable for initially stabilizing the patient. In order to breathemore effectively for the patient during cardiopulmonary resuscitation,and to prevent aspiration of stomach contents, an endotracheal tube (orET tube) is placed into the trachea. Longer-term care usually requiresattaching the patient to a ventilator (e.g., by means of theendotracheal tube). The transition from face mask to breathing throughthe endotracheal tube can be dangerous if insertion of the endotrachealtube takes too long, because the mask and oral airway must be removedand the flow of air/oxygen is interrupted while the endotracheal tube isinserted through the patient's mouth.

The typical conventional approach to making this transition involvesdiscontinuing resuscitation and completely removing the mask and oralairway to expose the mouth. The physician inserts a rigid laryngoscopeblade into the patient's mouth to ensure that the patient's airway isopen, and then attempts to insert the endotracheal tube through thepatient's mouth and into the trachea in the conventional manner. Thismay require a significant amount of time, particularly if the patient isless than completely cooperative and relaxed, or if the patient's airwayhas suffered trauma, or the tongue has fallen back to close the airway.The patient may not be breathing during this time, or may not bebreathing sufficiently to maintain adequate blood oxygen levels. If thetransition process takes more than a few seconds, the physician musttemporarily abandon the effort and return to resuscitation byreinserting the oral airway and replacing the face mask. The transitionprocess may have to be repeated several times before the endotrachealtube is successful installed. In addition, the speed with which thetransition process must be completed increases the chances of a mistakebeing made or unnecessary injury to the patient during the intubationprocedure.

Endotracheal tubes are also used in semi-emergency situations toventilate patients with respiratory failure who may be conscious orsemi-conscious. The conventional approach requires the patient to liestill while the physician inserts a rigid laryngoscope blade into thepatient's mouth and trachea. Delivery of ventilation and/or oxygen isalso interrupted during this period. The endotracheal tube is theninserted into place while the laryngoscope blade keeps the patient'sairway open. Successful intubation depends on the patient beingcooperative and completely relaxed, which unfortunately is often not thecase. Even with a cooperative patient, intubation is very uncomfortableand can cause the patient to panic due to the difficulty in breathingduring the procedure. This procedure can also result in a choking orgagging response that can cause the patient to regurgitate and aspiratecontents from the stomach. One conventional response to theseshortcomings has been to sedate the patient during intubation.Tranquilizers make the patient more cooperative and less likely to chokeduring intubation, but also tend to suppress the patient's breathing andblood pressure. These side effects may be unacceptable when dealing witha patient who already suffers from shallow or irregular breathing ordepressed blood pressure. Therefore, a need exists for an improveddevice to guide insertion of an endotracheal tube and ensure that thepatient's airway is open, and that also allows the patient to continueto receive air/oxygen during the insertion process.

A wide variety of devices that combine face masks with tubes forventilation (e.g., endotracheal tubes) have been used in the past,including the following:

    ______________________________________                                        Inventor   Patent No.      Issue Date                                         ______________________________________                                        Jeshuran   5,197,463       Mar. 20, 1993                                      Kondur     4,580,556       Apr. 8, 1986                                       Donmichael 4,497,318       Feb. 5, 1985                                       Dryden     4,256,099       Mar. 17, 1981                                      Buttaravoli                                                                              3,809,079       May 7, 1974                                        ______________________________________                                    

Jeshuran shows an anesthesia mask 28 that is initially placed over thepatient's mouth and nose as shown in FIG. 7 of the Jeshuran patent. Afiber optic 40 is inserted through an endotracheal tube, and thenthrough an opening in a two-piece core 84, 86, as shown in FIG. 9. Thefiber optic 40 is advanced into the trachea. The head 96 is thenunscrewed and the core segments 84, 86 are disassembled to allow theendotracheal tube to be inserted through the mask, as shown in FIG. 2.The fiber optic 40 serves as a guide for insertion of the endotrachealtube 46. The fiber optic 40 is then withdrawn and the endotracheal tubecuff 136 is inflated, as shown in FIG. 8. However, Jeshuran does notshow a curved guide to direct insertion of the fiber optic probe. Thephysician is faced with the problem of navigating the fiber optic probepast the patient's tongue and along the patient's airway.

Kondur discloses another example of a adapter 10 that allows insertionof an endotracheal tube 40 through the face mask 50 and nose of thepatient. Here again, no curved guide is provided.

Donmichael discloses an esophageal obturator for blocking aspiration ofstomach fluids while the face mask is being used for ventilating thelungs.

Dryden discloses a two-tube resuscitation system. One tube is used tosupply air to the trachea, while the other tube is used for aspirationor administering medication.

Buttaravoli discloses a resuscitator having a face mask 11 with a curvedtube 15 for supplying air to the patient's airway.

In addition, the prior art includes several references involvingintubating pharyngeal airways that have a curved central tubular member,including the following:

    ______________________________________                                        Inventor Patent No.       Issue Date                                          ______________________________________                                        Berman   4,054,135        Oct. 18, 1977                                       Berman   4,067,331        Jan. 10, 1978                                       Berman   4,068,658        Jan. 17, 1978                                       Berman   4,069,820        Jan. 24, 1978                                       ______________________________________                                    

The Berman patents show an intubating pharyngeal airway having a sideaccess for passage of a tube. The side opening can be expanded or closedby means of either a hinge on the opposite side wall of the tube or by acap.

3. Solution to the Problem

None of the prior art references uncovered in the search show a facemask that incorporates a port and a curved guide for directing a fiberoptic probe and endotracheal tube along the patient's airway whileresuscitation, cardiopulmonary resuscitation, artificial mask breathing,or oxygenation continues. After the distal end of the fiber optic probehas guided the endotracheal tube past the larynx into the trachea, thefiber optic probe is withdrawn and the endotracheal tube can be used tomore effectively "bag" the patient, or the patient can be connected toan external ventilator.

This system allows the endotracheal tube to be inserted and connected toa ventilator without interrupting resuscitation or oxygenation of thepatient via the face mask. In addition, the curved guide greatlysimplifies insertion of the fiber optic probe and endotracheal tube byproviding direction and maintaining an open passageway past thepatient's tongue and into the hypopharynx. The flow of air/oxygensupplied by the resuscitation bag tends to inflate the patient's mouthand airway, and thus also helps to maintain a passageway andvisualization for the fiber optic probe and endotracheal tube.

SUMMARY OF THE INVENTION

This invention provides a method and apparatus for guiding insertion ofan endotracheal tube into a patient's trachea during resuscitation byusing a face mask and a curved guide. The guide is inserted through aflexible port in the face mask and has a curved distal portion thatextends into the patient's mouth and hypopharynx. The patient isinitially resuscitated by supplying a flow of air/oxygen through themask. An endotracheal tube is inserted over the distal end of a fiberoptic probe. Resuscitation, oxygenation, or artificial ventilationcontinue without interruption while the fiber optic probe andendotracheal tube are inserted through a flexible port at the proximalend of the guide and then advanced along the guide into the patient'sairway. The direction of the distal tip of the fiber optic probe can becontrolled by the physician. This allows the physician to carefullyguide the fiber optic probe and endotracheal tube to a position past thelarynx while resuscitation continues. The fiber optic probe is thenremoved from within the endotracheal tube and the mask is removed whileleaving the endotracheal tube in place within the trachea. The cuff onthe endotracheal tube is inflated and a ventilator is connected to theproximal end of the endotracheal tube to ventilate the patient.Alternatively, the patient can be manually ventilated by connecting aresuscitation bag to the proximal end of the endotracheal tube.

A primary object of the present invention is to provide a method andapparatus for guiding insertion of an endotracheal tube that does notrequire interruption of the resuscitation process.

Another object of the present invention is to provide a method andapparatus for improving insertion of an endotracheal tube by helping tokeep the patient's airway open, and also allowing the physician to guidethe insertion process via the fiber optic probe.

Another object of the present invention is to provide a method andapparatus for instilling local anesthetic into the patient's airway andsuctioning excess secretions prior to insertion of the endotrachealtube.

Another object of the present invention is to provide a method andapparatus for guiding insertion of an endotracheal tube that lessens therisk of injury and reduces patient discomfort.

Yet another object of the present invention is to provide a device thatenables the physician to instill anesthetic and/or suction secretionsfrom the patient's mouth and airway as the device is inserted.

These and other advantages, features, and objects of the presentinvention will be more readily understood in view of the followingdetailed description and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention can be more readily understood in conjunction withthe accompanying drawings, in which:

FIG. 1 is a front perspective view of the face mask assembly, includingthe port 23 and curved guide 25.

FIG. 2 is a rear perspective view of the mask assembly corresponding toFIG. 1.

FIG. 3 is a cross-sectional view of the mask assembly corresponding toFIG. 1.

FIG. 4 is a front view of the face mask port 23 showing the elastic slot28 closed.

FIG. 5 is a cross-sectional view of the mouth and airway of a patientafter the mask 20 has been initially placed over the patient's mouth andnose with the curved guide 25 extending into the mouth, over the tongue14, and into the hypopharynx 15.

FIG. 6 is a cross-sectional view of the mouth and airway of the patientcorresponding to FIG. 5 after the fiber optic probe 30 and endotrachealtube 40 have been inserted through the face mask port 23 and advancedalong the curved guide 25 to a position below the larynx 18.

FIG. 7 is a front view of the mask port 23 corresponding to FIG. 6showing the fiber optic probe 30 and endotracheal tube 40 incross-section.

FIG. 8 is a cross-sectional view of the mouth and airway of the patientcorresponding to FIG. 5 after the fiber optic probe 30 has been removedfrom within the endotracheal tube 40.

FIG. 9 is a cross-sectional view of the mouth and airway of the patientcorresponding to FIG. 5 showing the face mask 20 being removed while theendotracheal tube 40 remains in place.

FIG. 10 is a cross-sectional view of the mouth and airway of the patientcorresponding to FIG. 5 after the mask 20 has been removed, theendotracheal tube cuff 44 has been inflated, and a ventilator 50 hasbeen connected to the endotracheal tube 40.

FIG. 11 is a cross-sectional view of the face mask 20 and guide 25 in analternative embodiment in which the curved guide 25 is configured as aoral airway that engages the posterior surface of the mask 20surrounding the face mask port 23.

FIG. 12 is a rear detail view of locking mechanism 21 used to engage thecurved guide 25 to the posterior surface of the mask 20.

DETAILED DESCRIPTION OF THE INVENTION

Turning to FIGS. 1 and 2, front and rear perspective views of thepresent invention are illustrated. A corresponding cross-sectional viewis shown in FIG. 3. The face mask 20 is adapted to fit over thepatient's mouth and nose for resuscitation of the patient 10 as shown inFIG. 5. The mask 20 has a low profile and is made of an elasticmaterial, such as rubber or flexible plastic, to allow the mask toconform to the contours of the patient's face and create a moreair-tight seal around the mouth and nose.

The face mask 20 includes a sealable port 23. In the preferredembodiment, the face mask port 23 consists of a flexible, elasticmembrane having a stretchable opening 24 with dimensions large enough toallow a curved guide 25 to pass through the face mask port 23. Forexample, this elastic membrane can be made of rubber with slot or holeforming an opening 24, as shown in FIG. 4.

As depicted in FIG. 5, the curved guide 25 can be readily insertedthrough the face mask port 23 while maintaining a substantiallyair-tight seal around the guide 25 to prevent gas from escaping fromwithin the face mask 20. The guide 25 is generally tubular and includesa sealable port 27 at its proximal end. For example, the guide port 27can be made of a flexible, elastic membrane having a stretchable slot oropening 28 with dimensions large enough to allow an endotracheal tube topass through the guide port 27. The guide 25 extends posteriorly throughthe face mask 20 and has a curved distal portion that is inserted intothe patient's mouth and hypopharynx 15 as the face mask 20 is placedover the patient's mouth. The distal portion of the curved guide 25generally follows the profile of a typical patient's airway through themouth, over the tongue 14, and into the hypopharynx 15 just above theopening to the trachea 16. The guide 25 is shaped to prevent thepatient's tongue 14 and collapsible pharynx from obstructing access tothe trachea 16, while also defining a channel for later insertion of anendotracheal tube. The guide 25 is typically made of plastic withsufficient strength and rigidity to keep the patient's teeth apart andprevent the patient from biting down on the endotracheal tube. The facemask port 23 allows the guide 25 to slide relative to the face mask 20,and also allows a limited range of rotation of the guide 25. Thisflexibility allows the guide 25 to accommodate a wide range of patientsizes and conditions.

In the preferred embodiment, the guide 25 is equipped with small tube 29bonded to the exterior of the guide 25 that extends along the length ofthe guide 25 to its distal end. This tube 29 can be used to suctionsecretions from the patient's mouth and airway as the guide 25 isadvanced. Alternatively a syringe 55 containing a local anesthetic(e.g., lidocaine or xylocaine) can be connected to the proximal end ofthe tube 29 to squirt anesthetic as the guide 25 is insert through thepatient's mouth and into the hypopharynx 15, as illustrated in FIG. 5.If squirted with sufficient force, the anesthetic can be carried as faras the larynx 18 to deaden any discomfort associated with insertion ofthe endotracheal tube 40. Alternatively, the physician can squirtanesthetic directly down the main passageway of the guide 25. The mainpassageway can also be used for suctioning secretions from the patient'smouth and airway.

The patient is initially resuscitated by supplying a flow of air/oxygenthrough the mask. For example, the flow of air can be supplied by aresuscitation bag 22 attached to the mask 20 that is manually squeezedperiodically to simulate natural breathing. However, other conventionalair/oxygen supplies for resuscitation could be substituted at theconnector 23 for the face mask 20. In the preferred embodiment, the flowof oxygen/air from the resuscitation bag 22 is directed around theexterior of the curved guide 25. This tends to inflate the patient'smouth and airway, which distends the collapsible tissues, and therebymakes visualization and insertion of the endotracheal tube 40 easier.

After the patient's conditioned has been stabilized to some degreeduring initial resuscitation, an endotracheal tube 40 is inserted over afiber optic probe 30. The fiber optic probe 30 and endotracheal tube 40are then inserted through the guide port 27 and along the guide 25 to aposition within the trachea 16 past the larynx 18 while resuscitationcontinues, as illustrated in FIG. 6. The opening 28 in the flexiblemembrane stretches to allow the endotracheal tube 40 and fiber opticprobe 30 to pass through the guide port 27, but maintains a sufficientlytight fit around the endotracheal tube 40 to prevent the escape of gasfrom within the mask 20, as shown in the front view of the face maskprovided in FIG. 7.

The fiber optic probe 30 allows the physician to view within thepatient's mouth and trachea 16 during insertion. The physician can alsoremotely manipulate the direction of the probe tip 32 to control thedirection of the fiber optic probe 30. This minimizes patient discomfortand risk of injury to the patient. The small size of the fiber opticprobe 30 also allows the physician to thread the fiber optic probe 30through relatively constricted areas within the airway, such as thelarynx 18. Most importantly, the fiber optic probe 30 and endotrachealtube 40 do not interfere with ongoing resuscitation of the patient.

The distal end 46 of the endotracheal tube 40 can beveled as illustratedmost clearly in FIG. 6. Experience has shown that injury to the larynx18 can be reduced by spinning the endotracheal tube 40 as it isadvanced. The beveled end tends to keep the endotracheal tube 40centered as it is passes through the vocal cords. Injury to the liningof the mouth and trachea can be reduced by using an endotracheal tube 40made of a material having a low coefficient of friction, such assilicone. Bivona Medical Technologies of Gary, Ind., markets a line ofendotracheal tubes made of silicone with a helical reinforcing wire.

After the endotracheal tube 40 has been inserted, the fiber optic probe30 is removed from within the endotracheal tube 40 through the proximalend of the endotracheal tube 40, as depicted in FIG. 8. The face mask 20and guide 25 can then be removed while leaving the endotracheal tube 40in place within the trachea 16, as shown in FIG. 9. The opening 28 inthe flexible port 27 allows the face mask 20 and guide 25 to bewithdrawn over the connector 42 at the proximal end of the endotrachealtube 40 with minimal effort and dislocation of the endotracheal tube 40.The position of the endotracheal tube 40 can be stabilized while themask 20 is removed by manually gripping the proximal end of theendotracheal tube 40 and gradually urging it through the port 27 as themask 20 is lifted from the patient's face. The physician can then reachunder the face mask 20 to grip the endotracheal tube 40 after the mask20 has been lifted sufficiently to allow access.

Alternatively, the face mask 20 can be removed while leaving the guide25 in place to serve as an oral airway and to protect the endotrachealtube 40 from being bitten by the patient's teeth. After the face mask 20has been removed, the endotracheal tube is taped to the patient's face,or held in place by some other suitable means for attachment.

The cuff 44 at the distal end 46 of the endotracheal tube 40 is theninflated through the port valve 45 to block the trachea 16. An externalventilator 50 can be attached to the connector 42 at the proximal end ofthe endotracheal tube 40, as shown in FIG. 10. The patient can then bemechanically ventilated in the conventional manner via the endotrachealtube 40. Alternatively, the patient can be manually ventilated byattaching a resuscitation bag to the connector 42 at the proximal end ofthe endotracheal tube.

It should be understood that the guide 25 and mask 20 can have anynumber of possible embodiments. The embodiment shown in the drawingsuses a guide 25 that extends through an elastic port 23 in the face mask20. This allows a limited range of motion between the guide 25 and mask20 to make insertion of the guide easier, but requires two elastic ports23 and 28. Alternatively, the guide 25 and mask 20 could be fabricatedas two separate pieces that engage one another, as illustrated in FIG.11. This eliminates the need for the guide port 27. In this embodiment,the guide 25 is separately inserted into the mouth, similar to aconventional oral airway. The mask 20 is then placed over the patient'smouth and nose so that the proximal end of the guide 25 engages acorresponding opening in the posterior face of the mask 20 to provide arelatively continuous passageway for insertion of the fiber optic probe30 and endotracheal tube 40 through the face mask port 23 and along theguide 25. FIG. 12 provides a rear detail view of the locking mechanism21 used to engage the guide 25 to the posterior face of the mask 20. Theguide 25 can be readily disengaged by rotating it slightly relative tothe face mask 20. After the endotracheal tube 40 has been inserted, themask 20 is removed while leaving the guide 25 in place within thepatient's mouth. The guide 25 remains around the endotracheal tube 40and protects it from being bitten or crimped by the patient's teeth.

The guide 25 can consist of a tubular member as shown in the drawings.Alternatively, the distal portion of the guide 25 can have a U-shapedcross-section. The guide 25 can be molded from a suitable plasticmaterial having a relatively low coefficient of friction to minimizeirritation to the lining of mouth and trachea and to minimize resistanceto insertion of the endotracheal tube 40 along the guide. Friction canbe further reduced by applying a slippery coating to both the exteriorand interior surfaces of the guide 25. A slippery coating can also beapplied to the endotracheal tube to minimize friction between theendotracheal tube and the guide.

All of the components necessary to practice the present invention can bereadily packaged as a kit for use in emergency rooms and intensive careunits. The kit is sufficiently compact and inexpensive that it can bestocked on resuscitation carts; widely used in hospitals, and carried inambulances for use by emergency medical technicians in the field. Thefiber optic probe can be operated using a battery-powered light source.The oxygen supply for the hospital or ambulance can be connected to theface mask 20 for resuscitation or to provide a flow of gas to theventilator 50. The tube 29 extending along the guide 29 can also beconnected to the suction system provided by the hospital or ambulance,if necessary.

The above disclosure sets forth a number of embodiments of the presentinvention. Other arrangements or embodiments, not precisely set forth,could be practiced under the teachings of the present invention and asset forth in the following claims.

I claim:
 1. An apparatus for guiding insertion of an endotracheal tubeinto the trachea of a patient, said apparatus comprising:a face mask forcovering a patient's mouth and nose; means for supplying a flow ofair/oxygen into said mask to resuscitate a patient; a resealable facemask port; and a guide removably extending through said face mask porthaving:(a) a curved distal portion for insertion into a patient's mouthand hypopharynx; said guide directing insertion of an endotracheal tubeinto a patient's trachea; and (b) a guide port allowing removableinsertion of the endotracheal tube along said guide;wherein said facemask port seals about said guide during insertion of said guide, andreseals to substantially close said face mask port after removal of saidguide.
 2. The apparatus of claim 1 wherein said guide comprises a tubehaving a curved distal portion.
 3. The apparatus of claim 1 wherein saidmeans for supplying a flow of air/oxygen to said mask comprises aresuscitation bag attached to said mask.
 4. The apparatus of claim 1wherein said flow of air/oxygen is directed around the exterior of saidguide.
 5. The apparatus of claim 1 wherein said guide port furthercomprises a flexible membrane having a stretchable opening for receivingsaid endotracheal tube.
 6. The apparatus of claim 1 wherein said facemask port comprises a flexible membrane having a stretchable opening forreceiving said guide.
 7. The apparatus of claim 1 wherein said guide hasa substantially U-shaped cross-section.